Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a) — a key marker for hereditary cardiovascular risk

May 23, 2024
The test has been developed in collaboration with Amgen.

Roche announced that the Tina-quant lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) to identify patients who may benefit from innovative Lp(a)-lowering therapy currently in development.

Lipoprotein (a), or Lp(a), is emerging as an important, yet under-recognized, potential risk factor for cardiovascular disease, a major public health issue.

Once approved, the new Tina-quant test is expected to be made available to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy.

Roche release